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Avcoo Pain Relief Roll-on

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Active ingredient
Menthol 4 g/100 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
January 5, 2025
Active ingredient
Menthol 4 g/100 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2025
Label revision date
January 5, 2025
Manufacturer
ADP Health Limited
Registration number
M017
NDC root
84992-001

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Drug Overview

You can use this medication for temporary relief from minor aches and pains associated with sore muscles and joints. It is designed to help you feel more comfortable and manage discomfort effectively. If you're experiencing these types of pain, this drug may be a suitable option to consider for alleviating your symptoms.

Uses

You can use this medication for the temporary relief of minor aches and pains in your sore muscles and joints. It’s designed to help you feel more comfortable when dealing with these everyday discomforts.

Rest assured, there are no concerns regarding teratogenic effects (which means it doesn’t cause birth defects) or nonteratogenic effects (which refers to other potential harmful effects unrelated to birth defects) associated with this medication.

Dosage and Administration

To use this medication, apply a thin film directly to the affected area of your skin. You can do this no more than 3 to 4 times each day. After applying the medication, make sure to wash your hands with cold water to avoid spreading it to other areas.

If you are considering this treatment for a child under 12 years old, it’s important to consult a doctor first before use. This ensures the safety and appropriateness of the medication for younger patients.

What to Avoid

You should avoid using this product if you are allergic to any of the ingredients listed on the package. Additionally, do not use it if the package is damaged or has been opened, as this could compromise safety. It's important not to apply this product simultaneously with other topical analgesics (pain-relieving medications applied to the skin) or on sensitive areas such as mucous membranes, cuts, broken skin, swollen, or irritated skin. Following these guidelines will help ensure your safety and the effectiveness of the product.

Side Effects

When using this product, it's important to remember that it is for external use only and should be kept away from heat and open flames, as it is flammable. Avoid applying it to wounds or damaged skin, and do not bandage tightly or use it with heating devices. Be careful to keep it away from your eyes.

If your condition worsens, or if symptoms last more than 7 days or return after improvement, you should stop using the product and consult a doctor. Additionally, seek medical advice if you notice any signs of skin injury, such as redness, irritation, swelling, or blistering.

Warnings and Precautions

Please read all directions and warnings carefully and use this product only as directed. It is for external use only and is flammable, so keep it away from heat and open flames. Avoid applying it to wounds or damaged skin, and do not bandage tightly or use with heating pads. Be cautious to keep it away from your eyes and do not use it on mucous membranes or irritated skin.

If you are allergic to any of the ingredients, or if the package is damaged or opened, do not use the product. Avoid using it alongside other topical pain relievers. If you accidentally swallow the product, seek medical help or contact a Poison Control Center immediately.

You should stop using the product and consult your doctor if your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days. Additionally, seek medical advice if you notice any signs of skin injury, such as redness, irritation, swelling, or blistering.

Overdose

If you suspect an overdose, it's important to be aware that there may not be specific information available about the effects or treatment for this situation. However, you should always take any signs of overdose seriously. Common signs can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or suspect an overdose, seek immediate medical help. It's better to be cautious and get professional assistance to ensure your safety. Always remember that timely action can make a significant difference in any emergency situation.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with your healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you may consider during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with your healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you are considering this medication for your child, it's important to know that it is not recommended for children under 12 years of age. If your child is younger than this age, please consult a doctor for advice on appropriate treatment options. Always prioritize your child's safety and well-being by seeking professional guidance when it comes to their health.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to be adjusted based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific condition. They can help monitor your kidney health and make any necessary changes to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to be cautious when using this medication. You should not use it at the same time as other topical analgesics (pain-relieving creams or gels applied to the skin). Mixing these products can increase the risk of side effects or reduce their effectiveness.

Always discuss any medications you are taking, including over-the-counter products, with your healthcare provider. They can help ensure that your treatment is safe and effective, and they can provide guidance on how to use your medications properly.

Storage and Handling

To ensure the best performance of your product, store it in a dry place at room temperature, ideally between 20-25°C (77-86°F). It's important to keep it away from direct sunlight, as exposure can affect its quality.

When handling the product, make sure to maintain a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the product's effectiveness.

Additional Information

You should apply a thin film of the medication to the affected area, doing this no more than 3 to 4 times a day. It's important to follow this guideline to ensure safe and effective use of the product. If you have any questions or concerns about your treatment, be sure to consult with your healthcare provider.

FAQ

What is the primary use of this drug?

This drug provides temporary relief from minor aches and pains of sore muscles and joints.

How should I apply this drug?

Rub a thin film over the affected area no more than 3-4 times daily.

Are there any age restrictions for using this drug?

Do not use this drug on children under 12 years of age without consulting a doctor.

What should I do if I experience worsening symptoms?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

What precautions should I take when using this drug?

For external use only; keep away from heat and open flame, avoid contact with eyes, and do not apply to wounds or damaged skin.

What should I do if I accidentally swallow this drug?

If swallowed, get medical help or contact a Poison Control Center right away.

Can I use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a healthcare professional before use.

What should I do if the package is damaged?

Do not use the drug if the package arrives damaged or opened.

Are there any contraindications for using this drug?

Do not use if you are allergic to the listed ingredients or if you are using other topical analgesics.

Packaging Info

Below are the non-prescription pack sizes of Avcoo Pain Relief Roll-on (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Avcoo Pain Relief Roll-on.
Details

Drug Information (PDF)

This file contains official product information for Avcoo Pain Relief Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The recommended application involves rubbing a thin film of the product over the affected area, not exceeding 3 to 4 times daily. It is essential for healthcare professionals to advise patients to wash their hands thoroughly with cold water after each application to prevent unintentional contact with other areas of the body or with other individuals.

For pediatric patients, it is important to note that the product is not recommended for use in children under 12 years of age. In such cases, consultation with a healthcare provider is advised prior to use.

Contraindications

Use is contraindicated in the following situations:

  • Patients with a known allergy to any of the listed ingredients should not use this product due to the risk of allergic reactions.

  • The product should not be used if the package is damaged or opened, as this may compromise safety and efficacy.

  • Concurrent use with other topical analgesics is contraindicated to avoid potential additive effects or adverse reactions.

  • Application on mucous membranes, cuts, broken, swollen, or irritated skin is prohibited to prevent irritation or exacerbation of the condition.

Warnings and Precautions

Healthcare professionals are advised to adhere strictly to the following warnings and precautions when administering this product.

Warnings

It is imperative to read all directions and warnings thoroughly and to use the product only as directed. This formulation is intended for external use only. Due to its flammable nature, it must be kept away from excessive heat and open flames. Care should be taken to avoid bandaging tightly or using heating pads or devices in conjunction with this product. Contact with the eyes must be avoided, and it should not be applied to wounds or damaged skin.

General Precautions

Patients should not use this product if they have a known allergy to any of the listed ingredients. Additionally, the product should not be used if the packaging is damaged or has been opened prior to use. Concurrent use with other topical analgesics is contraindicated. The product is also not suitable for application on mucous membranes, cuts, broken, swollen, or irritated skin.

Emergency Medical Help Instructions

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Stop Taking and Call Your Doctor Instructions

Patients should discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, they should stop use and seek medical advice if any signs of deterioration or skin injury occur, including redness, irritation, swelling, or blistering.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is flammable; therefore, it should be kept away from excessive heat and open flames. Patients are advised not to bandage the area tightly or use it in conjunction with heating pads or devices. Additionally, contact with the eyes should be avoided, and the product should not be applied to wounds or damaged skin.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should stop use and consult a doctor. Furthermore, any signs of deterioration or skin injury, including redness, irritation, swelling, or blistering, warrant immediate medical attention.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated. The combination may increase the risk of adverse effects without providing additional therapeutic benefit. It is advised to avoid using multiple topical analgesics simultaneously to ensure patient safety and optimal therapeutic outcomes.

Packaging & NDC

Below are the non-prescription pack sizes of Avcoo Pain Relief Roll-on (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Avcoo Pain Relief Roll-on.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a healthcare professional. It is important for healthcare providers to evaluate the appropriateness of treatment in this age group, considering potential risks and the need for alternative therapies.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive measures. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise following excessive administration of the product.

Management Procedures Management of overdosage should be tailored to the individual patient, taking into account their medical history and the context of the overdose. Consultation with a poison control center or a medical toxicologist may be beneficial for guidance on further management strategies.

In summary, due to the lack of specific overdosage information, healthcare professionals are encouraged to apply standard overdosage protocols and remain observant for any adverse effects that may necessitate intervention.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children and pets to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately. This precaution is essential to ensure the safety of both children and pets.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers. It should be stored in a dry place at room temperature, ideally between 20-25°C (77-86°F). Care should be taken to keep the product away from direct sunlight to maintain its integrity and efficacy.

Additional Clinical Information

Patients should apply a thin film of the medication over the affected area, ensuring that it is used no more than 3-4 times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Avcoo Pain Relief Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Avcoo Pain Relief Roll-on, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.